Vessel Sealing Device

ABSTRACT

A seal assembly that seals opening in the wall of a blood vessel has a first sealing element for placing inside the lumen of the blood vessel and to engage the interior wall surface, a shaft integrally formed with the first sealing element and fixed in a predetermined configuration relative to the first sealing element, an outer floating element slidingly movable along the shaft; and a second sealing element, the second sealing element slidingly movable relative to the first sealing element along the shaft to engage the outer floating element and position the outer floating element against the exterior surface and the first sealing element against the interior surface of the blood vessel to seal the opening in the blood vessel.

BACKGROUND OF THE INVENTION

This application is a continuation-in-part application of applicationSer. No. 13/746,278, filed on Jan. 21, 2013, issued on Sep. 22, 2015 asU.S. Pat. No. 9,138,215, the contents of which are incorporated byreference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to a sealing device for theclosure of puncture holes in blood vessels and, in particular, to asealing device that does not require a sheath change and is simple tooperate.

TECHNICAL BACKGROUND

For many diagnostic and interventional procedures it is necessary toaccess arteries or veins. Vessel access is accomplished either by directvision or percutaneously. In either case, the target vessel is puncturedwith a hollow needle containing a tracer wire. When the intravascularpositioning of the tracer wire has been verified, the hollow needle isremoved leaving the tracer wire. Next, a sheath containing a dilator ispushed in over the tracer wire. The dilator enlarges the punctureopening to facilitate the insertion of the larger diameter sheath intothe blood vessel. The sheath usually consists of a hollow tube with anopen distal end and a hemostatic valve at a proximal end, which remainsoutside the body and blood vessel. The hemostatic valve is made of acompliant material and is designed in such a way as to allow devicessuch as catheters to be inserted and withdrawn from the blood vesselwith minimal blood loss. After the sheath has been inserted into theblood vessel, the dilator is removed leaving a clear passageway in thesheath for the catheter. The sheath is removed from the blood vesselafter the procedure is finished resulting in bleeding at the puncturesite that must be staunched.

Traditionally, pressure is applied at the puncture site to allow theblood to clot, thereby stopping the bleeding. Depending on the amount ofanticoagulants that may have been administered to the patient during andprior to the procedure, the time that the pressure must be maintainedvaries from 15 minutes to more than an hour. Once bleeding has stopped,a pressure bandage is placed over the site of the puncture in an attemptto protect the integrity of the clot. The pressure bandage must remainin place for some time, usually from 8 to 24 hours. During this periodof time the patient must remain in bed, sometimes requiring an overnighthospital stay.

To shorten the length of time required for the patient to becomeambulatory and to lessen complications that may arise from thetraditional method of sealing the opening, several closure devices havebeen developed. One such device, as described in U.S. Pat. No.5,620,461, is a foldable sheet with an attachment thread that isinserted into the opening in the blood vessel and an arresting elementthat is applied over the attachment element against the outside of theblood vessel. Another such device is described in U.S. Pat. Nos.6,045,569 and 6,090,130, and includes an absorbable collagen plugcinched down against an absorbable intervascular anchor via anabsorbable suture. The absorbable intervascular anchor has an elongatedrectangular shape that requires it to be inserted into the puncturewound with its longitudinal axis approximately parallel to the sheathaxis. This requires it to be rotated ninety degrees after insertion sothat blood flow obstruction is minimized. A specially designed sheath isnecessary to assure proper rotation, thus resulting in an otherwiseunnecessary sheath change. The long dimension of the anchor is thuslarger than the cannula inside diameter (ID) and the width is smallerthan the ID. The collagen plug is in an elongated state prior todeployment and is forced into a ball shape via a slipknot in the suture,which passes through the collagen, and a tamper that applies a distalforce to it. The anchor acts as a support for the suture cinch whichforces the collagen ball shape up against the exterior blood vessel walland the anchor. Blood flow escaping around the anchor is slowed down andabsorbed by the collagen material and thus forms a clotting amalgamationoutside the blood vessel that is more stable than the traditional methodof a standalone clot. The added robustness of the amalgamation clotallows earlier ambulation of the patient.

The device raises several issues. It is not a true sealing device butrather a clotting enhancement device, as opposed to a device with twoflat surfaces exerting sealing pressure on both the interior andexterior of the blood vessel, a much more reliable technique. In eithercase, bleeding occurs during the time between removal of the sheath andfull functionality of the deployed device. Thus “instant” sealingpressure from two flat surfaces is desirable over a method that reliesto any extent on clotting time. One such device is disclosed by Bateset. al. in U.S. Pat. No. 8,080,034. The '034 device comprises aninternal sealing surface pivoting on a rigid post to accommodate thelongitudinal dimension of the seal inside the sheath ID. The exteriorseal (second clamping member) is slidable along the rigid post andpivotal such that it, along with the internal seal, sandwiches the wallof the blood vessel via a locking ratchet. One problem with this designis that the pivoting feature increases the cross-sectional dimension ofthe seal thus requiring a larger diameter sheath than would be otherwiseneeded. In addition, the pivoting internal seal has no means to assurethat the seal pivots to the correct sealing position as the ratchetcloses. This could cause the internal seal to exit the blood vessel inthe collapsed configuration as the user withdraws the deploying device.In addition no specific mechanism for the release of the seals from thedeployment instrument is disclosed, other than a general statement “anyknown means.”

The seals are released by the user cutting the suture thread in thedevice described in U.S. Pat. No. 6,045,569.

It is known that the opening in the blood vessel closes to some extentafter the sheath is removed, thus allowing smaller seal surfaces thanwould otherwise be required. What is less known is that the opening doesnot close as quickly as a truly elastic material such as natural rubberor latex. For this reason, seal surfaces of closure devices that areactivated in less than a second, or perhaps even longer, after sheathremoval must be physically larger than the sheath outside diameter toavoid embolization of the seals because of the delayed blood vesselclosure. The design of seals that are deployed through a sheath ID withdimensions larger than the sheath OD upon deployment is a challengesince the preferred material for seals are bio-absorbable and thus havelimited mechanical properties.

An active sealing assembly comprising solid, flat interior and exteriorelements that sandwich the blood vessel wall to insure hemostasis andyet have major dimensions that exceed the interior diameter of theintroducer sheath to compensate for slow, partial closure of the woundupon removal of the sheath thereby minimizing leakage and avoidingembolization of the sealing components offers a design challenge.Components can be introduced through the sheath internal diameter (ID)longitudinally and rotated into a position adjacent to the blood vesselwall such that the longitudinal dimension exceeds the sheath ID withlittle or no concern regarding the mechanical properties of thematerial. The devices in the '461 and '034 patents are examples. Asnoted previously, these solutions have severe limitations.

Another method of accomplishing the desired result of obtaining adeployed seal larger than the sheath ID is to fold the seal elementswhile they traverse the sheath ID and reopen them upon deployment.Optimally, the major dimension of the seal elements should be 1.5 to 2times larger than the outside diameter of the sheath. The '569 Patentdiscloses an external seal made of an elongated pliable collagen plugthat swells upon absorbing blood leaking from the wound and is tampedinto more or less of a ball larger than the opening of the wound. Theinternal seal is inserted longitudinally through a special sheath which,with the aid of an attachment thread, rotates the seal parallel to theblood vessel surface.

The '569 device requires removing the catheter sheath and replacing itwith a custom sheath prior to deployment, resulting in additional bloodloss. The tamping force used to deploy the collagen against the anchoris left to the surgeon's feel, sometimes resulting in inadequatedeployment and other times resulting in the collagen being pushedthrough the puncture wound and into the blood vessel along with theanchor. Inadequate tamping results in excessive bleeding with thepotential for painful hematoma and over tamping can require a surgicalprocedure to remove the device from the blood vessel lumen. In addition,the absorption rate of the suture, the collagen, and the anchor may bedifferent owing to the fact that they are formed from differentmaterials, sometimes resulting in the premature detachment of theanchor, which can move freely in the blood stream and become lodged inthe lower extremities of the body, again requiring surgical removal.

U.S. Pat. No. 5,350,399 discloses umbrella-shaped foldablebio-compatible seals that are not bioabsorbable.

It would be desirable therefore to provide a vessel-sealing device thatactually seals the blood vessel and does not rely on the clotting of theblood. It is also desirable to provide a closure device that isdeployable through the catheter sheath with minimal steps requiring lessthan 2 minutes for hemostasis. It would be also desirable to provide areliable, active vessel-sealing device comprising a bio-absorbable sealassembly with deployed major dimensions larger than the sheath outsidediameter.

SUMMARY OF THE INVENTION

Disclosed herein is a seal assembly for sealing an opening in the wallof a blood vessel, the blood vessel having an interior wall surface,exterior wall surface, and a lumen, the seal assembly the includes afirst sealing element for placing inside the lumen of the blood vessel,a shaft formed with the first sealing element as a single one-piececomponent, the shaft fixed in a predetermined configuration relative tothe first sealing element, the shaft having a length sufficient toextend through the opening of the blood vessel and at least a portion ofany overlying tissue, a flexible member surrounding at least a portionof the shaft adjacent the first sealing element, an outer floatingelement slidingly movable along the shaft, the outer floating elementhaving a proximal surface and a distal surface, and a second sealingelement, the second sealing element slidingly movable relative to thefirst sealing element along the shaft to engage the outer floatingelement and configured to position the distal surface of the outerfloating element against the exterior wall surface and the flexiblegasket against the interior wall surface of the blood vessel to seal theopening in the blood vessel.

In some embodiments, the flexible member is secured to a proximallyfacing surface of the first sealing element.

In some embodiments, the shaft has at least two sides, the at least twosides each having a groove along a portion thereof and the outerfloating element has an aperture to receive the shaft therethrough, theaperture generally being rectangular and having two protrusionsextending into the aperture and configured to the groove on a respectiveside of the shaft.

In some embodiments, each of the protrusions has a first surface capableof engaging a first wall of the groove and a second surface capable ofengaging a second wall of the groove and when the first surface engagesthe first wall of the groove, the distal surface of the outer floatingelement is disposed relative to the first wall at an angle of between 35and 55 degrees.

In other embodiments, the device includes an inserter, the inserterincludes a housing have a first portion and a second portion, the firstportion and second portion having a proximal end and a distal end, alongitudinal opening extending through the housing when the first andsecond portion are connected to one another and opening at the proximaland distal ends, and an aperture in one of the first and secondportions, the aperture configured to receive a portion of the firstsealing element when the first and second portion are connected to oneanother and the seal assembly is inserted therein.

In another aspect, the present invention is directed to method ofsealing an opening in the wall of a blood vessel, the blood vesselhaving an interior wall surface, exterior wall surface, and a lumen, themethod including providing a seal assembly for sealing the opening inthe blood vessel, the seal assembly operatively connected to aninsertion device and comprising a first sealing element for placinginside the lumen of the blood vessel, a shaft formed with the firstsealing element as a single one-piece component, the shaft fixed in apredetermined configuration relative to the first sealing element, theshaft having a length sufficient to extend through the opening of theblood vessel and at least a portion of any overlying tissue, a flexiblemember surrounding at least a portion of the shaft adjacent the firstsealing element, an outer floating element slidingly movable along theshaft, the outer floating element having a proximal surface and a distalsurface, and a second sealing element, the second sealing elementslidingly movable relative to the first sealing element along the shaftto engage the outer floating element and configured to position thedistal surface of the outer floating element against the exterior wallsurface and the flexible gasket against the interior wall surface of theblood vessel to seal the opening in the blood vessel, inserting aportion of the seal assembly into the lumen of the blood vessel, andretracting the seal assembly and insertion device until the first sealelement and flexible member engages the interior wall surface of theblood vessel and causes the insertion device to automatically actuatethereby pushing the second sealing element and the outer floatingelement toward the exterior wall surface to position the outer floatingelement against the exterior surface and causing the shaft to break at areduced portion disposed within the shaft.

Additional features and advantages of the invention will be set forth inthe detailed description which follows, and in part will be readilyapparent to those skilled in the art from that description or recognizedby practicing the invention as described herein, including the detaileddescription which follows, the claims, as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description of the present embodiments of theinvention are intended to provide an overview or framework forunderstanding the nature and character of the invention as it isclaimed. The accompanying drawings are included to provide a furtherunderstanding of the invention and are incorporated into and constitutea part of this specification. The drawings illustrate variousembodiments of the invention and, together with the description, serveto explain the principles and operations of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a sealing deviceaccording to the present invention;

FIG. 2 is a perspective view of a portion of the sealing device of FIG.1 illustrating the seal assembly thereof;

FIG. 3A is a side plan view of the first sealing element and the shaft;

FIG. 3B is a bottom plan view of the first sealing element and theshaft;

FIG. 3C is a cross section view of the shaft at the location of thereduced portion;

FIG. 3D is a partial side view of the shaft at the location of thereduced portion;

FIG. 4A is a cross section view along a longitudinal axis of a secondsealing element of the seal assembly of FIG. 2;

FIG. 4B is a cross section view of the second sealing element of theseal assembly of FIG. 2 that is orthogonal to the view in FIG. 2;

FIG. 5A is a perspective view of a sheath introducer used with thesealing device of FIG. 1;

FIG. 5B is an exploded, perspective view of the sheath introducer ofFIG. 5A;

FIG. 6 is a cross section view of the seal assembly constrained in asheath introducer;

FIG. 7 is a top view of the sealing device with the sheath introducer ofFIG. 5A;

FIG. 8 is a perspective view of the sealing device inserted into a bloodvessel;

FIG. 9 is partial cross section view of a vessel with the sealing deviceinserted therein;

FIG. 10 is perspective view of the sealing device inserted into theblood vessel just before the sealing device is activated;

FIG. 11 is a perspective view of the seal assembly blocking the openingin the blood vessel after activation of the sealing device;

FIG. 12 is a stress-strain curve that illustrates the maximum strainwithout permanent deformation (yield point) is 4% for materials used inthe seal assembly of FIG. 1;

FIG. 13A illustrates a representation of strain that would be introducedinto the first sealing element on the top side thereof if constrained inthe sheath introducer of FIG. 5A;

FIG. 13B illustrates a representation of strain that would be introducedinto the first sealing element on the bottom side thereof if constrainedin the sheath introducer of FIG. 5A;

FIG. 13C is a legend for the strain representations of the first sealingelement constrained in the introducer;

FIG. 14 is a perspective view of another embodiment of a sealing deviceaccording to the present invention;

FIG. 15 is a perspective view of a portion of the sealing device of FIG.14 illustrating the seal assembly thereof;

FIG. 16A is an exploded, perspective view of the first sealing elementand the shaft;

FIG. 16B is a perspective view of the first sealing element and theshaft of FIG. 16A in an assembled state;

FIG. 16C is a top view of the first sealing element and shaft lookingdown the shaft;

FIG. 17 is a perspective view of the seal assembly of FIG. 15;

FIG. 18 is a side view of the of the seal assembly of FIG. 15;

FIG. 19 is is a bottom view of the of the seal assembly of FIG. 15;

FIG. 20 is a cross section view of the shaft at the location of thereduced portion;

FIG. 21 is a partial side view of the shaft at the location of thereduced portion

FIG. 22A is a cross section view along a longitudinal axis of a secondsealing element of the seal assembly of FIG. 16;

FIG. 22B is a cross section view of the second sealing element of theseal assembly of FIG. 16 that is orthogonal to the view in FIG. 24A;

FIG. 23A is a side view of a cross section of another embodiment of anouter floating member;

FIG. 23B is a top view of the outer floating member of FIG. 22A;

FIG. 24A is a side view of cross section view of the outer floatingmember in FIG. 22A in a first postion relative to the shaft;

FIG. 24B is a side view of cross section view of the outer floatingmember in FIG. 22A in a second postion relative to the shaft;

FIG. 25 is an exploded, perspective view of the sheath introducer foruse with the seal assembly of FIG. 16;

FIG. 26 is a cross section view of the seal assembly constrained in theinserter of FIG. 26;

FIG. 27 is a top view of the seal assembly in the bottom portion of theinserter;

FIG. 28 is a perspective view of the sealing device inserted into ablood vessel;

FIG. 29 is partial cross section view of a vessel with the sealingdevice inserted therein;

FIG. 30 is perspective view of the sealing device inserted into theblood vessel just before the sealing device is activated; and

FIG. 31 is a perspective view of the seal assembly blocking the openingin the blood vessel after activation of the sealing device;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferredembodiment(s) of the invention, examples of which are illustrated in theaccompanying drawings. Whenever possible, the same reference numeralswill be used throughout the drawings to refer to the same or like parts.

Referring to FIGS. 1 and 2, closure device 10 comprises two handlehalves 12,14 housing an automatic mechanism detailed in co-pendingapplication titled “Vessel Sealing Device with Automatic Deployment,”assigned Atty Docket SHJO-017 and assigned Ser. No. 13/746,276, thecontents of which are incorporated herein by reference in theirentirety. The automatic mechanism is coupled to the seal assembly 20 bya flexible pusher 16 and a flexible shaft 18. See also FIG. 6. Sealassembly 20 has a first sealing element 22, a knobbed rigid shaft 24, anouter floating element 26, and a second sealing element 28. Knobbed,rigid shaft 24 has a proximal section 30 and a distal section 32separated by a weakened notch feature 34, which is configured toseparate seal assembly 20 from the rest of the closure device 10 oncethe automatic deployment and sealing process is complete. The length ofthe distal section 32 of knobbed shaft 24 is dictated by the thicknessof the vessel wall that can be accommodated (see FIG. 10). The firstsealing element 22 also has a distal section 40 configured to interfacewith the inside wall of a vessel to be sealed (see also FIG. 9), aknobbed, rigid distal shaft section 32 (which is a part of the knobbed,rigid shaft 24), and ankle section 42 joining the distal section 40 tothe knobbed, rigid distal shaft section 32. The ankle section 42 isattached to distal section 40 at an angle α, which is preferably at anangle of about 45°. Although other angles may be used, the value ofangle α, may cause other values of the seal assembly to be changed, asdiscussed in detail below.

A more detailed view of the first sealing element 22 and the knobbedrigid shaft 24 are illustrated in FIGS. 3A-3D. The first sealing element22 has the distal section 40, ankle section 42 and the knobbed, rigiddistal shaft section 32. The distal section 40 has a proximal or topsurface 50, a bottom surface 52 and an outer peripheral surface 56. Theproximal or top surface 50 is preferably configured to engage theinterior wall surface 142 of the blood vessel 140 (see FIG. 9), whichmeans that the top surface 50 is preferably flat. However, the topsurface 50 can be of any configuration (e.g., flat, convex, etc) andstill come within the scope of the present invention. The bottom surface52 is preferably flat, but may have other configurations. As notedbelow, the exact configuration of the surfaces 50,52 may also depend onthe strain that is placed on them prior to and during insertion. Theouter peripheral surface 56 is preferably continuous in that it has nodiscontinuities. That is, the outer peripheral surface 56 is smooth andhas no sharp angles (e.g., 30, 45 or 90° angles). Since the distalsection 40 is to be deformed prior to insertion into the blood vessel140, any sharp angles tend to create stress points, potentially causingthe distal section 40 to be bent/deflected beyond its ability to returnto its original configuration. The distal section 40 has a thicknessthat increases from the front (or distal) end 58 to the rear (orproximal) end 60. In the embodiment illustrated in the figures, thethickness increases from 0.28 mm at the front end 58 to 0.30 mm at therear end 60. However, other thicknesses and tapered shapes fall withinthe scope of the present invention.

Illustrated in FIGS. 3C and 3D are a cross section of the knobbed rigidshaft 24 at the ankle 42 and partial side view of the knobbed rigidshaft 24 showing the weakened notch feature 34, respectively. The crosssection of the ankle 42 in FIG. 3C illustrates the shape of the ankle42, the knobs 62 on the upper 64 and the lower 66 surface, and thesmooth sides 68,70 of the knobbed rigid shaft 24, which cooperates withthe other portions of the first sealing element 22 to ensure that theouter floating element 26 and the second sealing element 28 are properlypositioned, as discussed in more detail below.

The weakened notch feature 34 is illustrated in FIG. 3D. The weakenednotch feature 34 has a smaller cross section than any other portion ofthe knobbed rigid shaft 24. This allows for the knobbed rigid shaft 24to be broken at this point upon activation of the insertion device inthe co-pending application by exerting a force in the direction of thelength of the knobbed rigid shaft 24, causing the knobbed rigid shaft 24to break at the weakened notch feature 34. In order to prevent theweakened notch feature 34 from breaking prematurely, a c-shaped ring 72is clipped into the weakened notch feature 34, as illustrated in FIG. 6.The width of notch feature 34 is sized to equal the space between knobs62 so that second seal 28 can easily transition over notch feature 34upon automatic activation of device 10. The c-shaped ring 72 preventsthe knobbed rigid shaft 24 from being tilted off center and breakingprematurely. The c-shaped ring 72 is preferably made from abio-absorbable material since the c-shaped ring 72 can separate fromboth the proximal section 30 and the distal section 32 of the knobbedrigid shaft 24 upon breaking of the weakened notch feature 34 and thereis no efficient way to retrieve it from the patient.

Second sealing element 28 is shown in more detail in FIGS. 4A and 4B.The second sealing element 28 has a proximally facing surface 80 and asloped distally facing surface 82. An internal opening 84 defined by theinternal surface 86 extends between the proximally facing surface 80 andthe sloped distally facing surface 82. The internal surface 86 hasextending therefrom and into the internal opening 84 projections 88 thatinterface with and engage the knobs 62 with an interference fit suchthat second sealing element 28 and knobbed rigid shaft 24 function as aone way latch assuring an adequate compression force regardless of theblood vessel wall thickness.

As can be best seen in FIG. 2, the proximal or top surface 50 of firstsealing element 22 lies in a first plane A and the sloped distallyfacing surface 82 of second sealing element 28 lies in a second plane B.Preferably, the first plane A and the second plane B are parallel to oneanother.

Referring to FIG. 4B, the internal opening 84 of second sealing element28 (and floating foot 26) have two flat surfaces 90 on opposite sides ofthe internal opening 84 that interface with flat surfaces 68,70 ofknobbed rigid shaft 24 to provide rotational stability of the sealassembly components 26,28 thus assuring that the sloped distally facingsurface 82 and the fully deployed floating foot 26 remain parallel withthe distal section 40 of the first sealing element 22 and the proximalor top surface 50 in particular.

FIGS. 5A and 6B depict introducer or outer sleeve 100, which isconfigured to protect seal assembly 20 from damage when inserting sealassembly 20 through a hemostatic valve, which, as discussed below and inmore detail in the co-pending application, is one method in which theseal assembly is inserted into the patient. Introducer 100 comprises twohalves, 102,104, which when assembled together form a generallycylindrical body having two different diameters. Front section 106 ofintroducer 100 has a smaller diameter than rear section 108. Frontsection 106 with the smaller diameter is configured to be inserted intohemostatic valve and rear section 108, having the larger diameterremains proximal to the hemostatic valve. While the two halves 102,104can be assembled according to any typical manner, pins 110 on one of thetwo halves 102,104 are configured with a press fit into correspondingmating holes 112 thus holding halves 102,104 firmly together.

The introducer 100 has an opening 114 that extends between the frontsection 106 and the rear section 108. However, within the opening 114are also grooves 116 that are configured to accept seal assembly 20. Theopening 114 is also configured to receive at least a portion of pusher16 of the seal device 10. FIG. 6 is a cross section of seal assembly 20in the initial position inside introducer 100 prior to insertion into asheath 120. The front end 58 and the rear end 60 of the distal portion40 of first sealing element 22 are deformed into a configuration suchthat the distal portion 40 of first sealing element 22 is able to passthrough the inside dimension of cannula 122 upon insertion of closuredevice 10 resulting in the configuration shown in FIG. 6. The initialposition of introducer 100 is shown in FIG. 7. After exit from distalend of cannula 122, the front end 58 and the rear end 60 of the distalportion 40 of first sealing element 22 return to the initialconfiguration as shown in FIG. 2 owing to the configuration shown inFIG. 6 not exceeding the elastic limit of the material from which theseal assembly 20 is constructed.

FIG. 8 depicts closure device 10 inserted into sheath 120, the distalend of which is inside blood vessel 140. Proximal end of sheath 120comprises hemostatic valve 132 attached to a funnel shaped sectiontransitioning into cannula 122 at the distal end.

A method of using the current invention, in conjunction with FIGS. 9-11,is as follows: providing a sheath introducer 100 that surrounds anddeforms seal assembly 20 such that seal assembly seal 20 can passthrough sheath valve 132. See also FIGS. 6 & 8. Inserting pusher 16through sheath 120, including valve 132 and cannula 122, causes at leasta portion of seal assembly 20 to exit the distal end of cannula 122 andinto blood vessel 140. A portion of the second sealing element 28 andthe pusher 16 may be disposed within the blood vessel 140. See FIG. 10.Pulling on the closure device 10, the proximal or top surface 50 of thedistal portion 40 of first sealing element 22 engages the interior bloodvessel wall 142. This would also remove the second sealing element 28and the pusher 16 from within the blood vessel 140. See FIG. 10.Continuing to pull on the sealing assembly 20 triggers an automaticmechanism in the closure device 10, which pushes pusher 16, and which inturn pushes second sealing element 28, and floating foot 26 (if present)distally such that floating foot 26 is in contact with outer wall ofblood vessel 140. This will sandwich the second sealing element 28against floating foot 26, blood vessel 140 and distal portion 40 offirst sealing element 22 such that the opening in blood vessel 140 ishemostatically sealed, as shown in FIG. 11.

To configure distal portion of first sealing element 22 such that theelastic limit of the bio-absorbable material is not exceeded whendeformed in introducer 100 and deployed through cannula 122, materialstudies were undertaken. Bio-absorbable materials comprising differentmole ratios of Lactide and Glycolide are commonly used for moldedimplant parts. These materials exhibit different properties such asglass transition temperature and absorption time; however the initialstrength and flexibility are similar. As an example, molded samples 1.6mm thick by 4 mm wide by 10 mm long of 85:15 L-Lactide:Glycolide withinherent viscosity of 2.1 dl/gm were tested in an Instron® UniversalTensile testing Machine Model 3340 according to ASTM E-8M-04 Standard ata crosshead speed of 2 inches/minute. A typical example of the stressstrain curve is shown in FIG. 12. Of particular interest is the factthat the maximum strain without permanent deformation (yield point) isseen to be 4% for materials of this type and particularly for 85:15L-Lactide:Glycolide with inherent viscosity of 2.1 dl/gm. Therefore, toassure no permanent deformation occurs for seal assembly 20 the maximumstrain while undergoing insertion into the blood vessel through sheath120 must be below 4%. It is worth noting that the yield point wasindependent of sterilization radiation level up to 50 KGy the maximumstrain at break decreased with radiation level however.

The strain induced into a sample under different stress loads isdependent on the material basic mechanical properties but as importantlythe geometric configuration. From a practical stand point closuredevices are most often used in 6 French or smaller sheaths for cardiacprocedures and up to 18 French or larger for AAA procedures. It is notedthat when the first sealing element 22 for a 6 French closure device, ismolded from 85:15 L-Lactide:Glycolide with inherent viscosity of 2.1dl/gm, the present design stays within the strain limits. In fact,Finite Element Analysis (FEA) of variations of the present designindicate that the continuous outer periphery and the thickness taperfrom 0.28 to 0.30 in distal portion of first sealing element 22, alongwith the oval configuration of ankle 42 are critical in keeping thestrain below 4% in the deformed state inside introducer 100, given theoverall size and shape of the sealing assembly. FIGS. 13A-C illustrateby a grayscale map the strain in sealing assembly 20 constrained inintroducer 100. It can be seen that the maximum strain is below 4% forthis configuration and material.

Turning to another embodiment, a closure device 300 is illustrated inFIGS. 14-32, comprises two handle halves 312,324 housing an automaticmechanism detailed in co-pending application titled “Vessel SealingDevice with Automatic Deployment,” assigned Atty Docket SHJO-017 andassigned Ser. No. 13/746,276, the contents of which are incorporatedherein by reference in their entirety. The closure device 300 is similarto the closure device disclosed in co-pending application Ser. No.13/746,276 and the embodiment above, with a different seal assembly 320.

More specifically and referring to FIG. 15, closure device 300 comprisestwo handle halves 312,314 that housing automatic mechanism 150. Theautomatic mechanism 150 interfaces with safety latch 152, which has asafety slide 154 that interacts with safety cage 156 via pin 158. Thesafety latch 152 operates such that with safety slide 154 in the distalmost position automatic mechanism 150 cannot be activated. The proximalmost position of safety slide 154 allows automatic activation. The pin158 is in the center of the underside of safety slide 154 and passesthrough handle opening 160 of handle half 312 and engages slot 162 ofsafety cage 156. With the safety slide 154 in the full distal position,the pin 158 forces safety cage 156 such that leg 164 is forced into aslot 166 in pusher 170 that locks the movable pusher 170 against distalmovement. In this position, safety slide 154 covers the word “READY” (orany other word, mark or appropriate indicia) and exposes the word “SAFE”(or any other word, mark or appropriate indicia) embossed on handle half312. In this position, the safety latch 152 prevents the automaticmechanism 150 from premature firing during shipment or handling. Withsafety slide 154 in the proximal-most position, the pin 158 forcessafety slide 154 to the right, thus removing leg 164 from the slot 166in pusher 170. In this position the automatic mechanism 150 is free toinitiate when first sealing element 320 interacts with the inside of avessel wall. In this configuration safety slide 154 covers the word“SAFE” and exposes the word “READY” on handle half 312.

Flexible pusher rod 316 is a cannulated cylinder, the proximal end ofwhich is connected by an adhesive or by another appropriate method tothe movable pusher 170. The movable pusher 170 has a front portion 172with an opening 174 for engagement with the flexible pusher rod 16 andto allow the flexible shaft 218 to pass through front portion 172. Thepusher 170 also has a rear portion 176 that is divided into an upperportion 176 a and a lower portion 176 b, the upper portion 176 a and alower portion 176 b defining an opening 178 therebetween.

The automatic mechanism 150 also includes a shaft retaining element 180that, in the initial or preactivation stage, is disposed in opening 178defined by the upper portion 176 a and a lower portion 176 b of pusher170. The shaft retaining element 180 also has an opening 182 passingtherethrough to allow the flexible shaft 318 to pass therethrough andextend proximally in the automatic mechanism 150. However, the flexibleshaft 318 is fixedly attached to the shaft retaining element 180. Theflexible shaft 318 therefore extends almost the entire length of thedevice 300. As noted above, the flexible shaft 318 is also connected tothe knobbed rigid shaft 326 of the seal assembly 320. A tensile force onthe flexible shaft 318 causes the automatic mechanism 150 to fire.

The automatic mechanism 150 also has a spring 190, which is illustratedas a cylindrical spring, but could be any resilient element and have anyconfiguration. The spring 190 engages, at its proximal end, the proximalend of the handle 312,314. The spring 190 is disposed around a springretainer 194 and engages at its distal end, the front end 196 of thespring retainer 194. The spring 190 is biased against the front end 196of the spring retainer 194 to push the spring retainer 194 against thepusher 170, as described in more detail below.

The automatic mechanism 150 also has two retention elements 200 that arerotatably mounted in the housing 312,314. The two retention elements 200are illustrated as being generally triangular, but could be of any shapeor configuration as long as they perform the functions noted below. Theretention elements 200 are disposed to engage the front end 196 of thespring retainer 194 and the shaft retaining element 180. In fact, eachof the two retention elements 200 engage a notch 202 on either side ofthe shaft retaining element 180. The retention elements 200 each have anend portion 204, preferably a flat surface, that engages an internalsurface of the notches 202. The retention elements 200 are disposed onround projections 206 extending upward from the handle 314. Theprojections 206 could also project downward from the handle 312.

With regard to the use of the device 300, the disclosure of the use ofthe device is discussed in detail in the co-pending Ser. No. 13/746,276,the content of which is incorporated herein by reference and summarizedagain below.

The automatic mechanism is coupled to the seal assembly 320 by aflexible pusher 316 and a flexible shaft 318, as in the priorembodiment. Seal assembly 320 has a first sealing element 322, aflexible member 324, a knobbed rigid shaft 326, an outer floatingelement 328, and a second sealing element 330. Knobbed, rigid shaft 326has a proximal section 332 and a distal section 334 separated by aweakened notch feature 336, which is configured to separate sealassembly 320 from the rest of the closure device 300 once the automaticdeployment and sealing process is complete. The length of the distalsection 334 of knobbed shaft 326 is dictated by the thickness of thevessel wall that can be accommodated. The first sealing element 322 alsohas a distal section 340 configured to, with the assistance of theflexible member 324, interface with the inside wall of a vessel to besealed; a knobbed, rigid distal shaft section 334 (which is a part ofthe knobbed, rigid shaft 326); and ankle section 342 joining the distalsection 340 to the knobbed, rigid distal shaft section 334. The anklesection 342 is attached to distal section 340 at an angle α, which ispreferably at an angle of about 45°. See FIG. 18. Although other anglesmay be used, the value of angle α may cause other values of the sealassembly to be changed. Applicant also notes the that the first sealingelement 322 is formed with the distal section 340, ankle section 342,and the knobbed, rigid shaft 326 at the same time and from the samematerial. As such, the first sealing element 322 is an integrally formedelement and the distal section 340 is not designed to move relative tothe knobbed, rigid distal shaft section 334 at any time, except throughdeformity. As indicated in the parent patent, the first sealing elementis preferably a one single-piece component.

A more detailed view of the first sealing element 322 and the knobbedrigid shaft 326 is presented in FIGS. 16A-21. The first sealing element322 has the distal section 340, ankle section 342 and the knobbed, rigiddistal shaft section 334. The distal section 340 has a proximal or topsurface 350, a bottom surface 352 and a heel 356. The top surface 350can be of any configuration (e.g., flat, convex, etc) and still comewithin the scope of the present invention. The bottom surface 352 ispreferably flat, but may have other configurations as well. The heel 356preferably has a greater thickness than the remainder of the distalsection 340 and, as discussed below is disposed into a cavity in theinserter. The distal section 340 has a thickness that increases from thefront (or distal) end 358 to the rear (or proximal) end 360. In theembodiment illustrated in the figures, the thickness increases from 0.28mm at the front end 358 to 0.30 mm at the rear end 360. However, otherthicknesses and tapered shapes fall within the scope of the presentinvention.

A top view of the knobbed, rigid shaft 326 and the first sealing element322 is illustrated in FIG. 16C. The knobbed, rigid shaft 326 has aproximal end 338 that may be connected to the flexible shaft 318 in anyappropriate fashion, e.g., glued, soldered, press-fit, friction fit,etc. Alternatively, the flexible shaft 318 may also be integral with theknobbed, rigid shaft 326, i.e., be formed at the same time with the samematerial making it an “integral” piece. The knobbed, rigid shaft 326 hasknobs 362 along the upper surface 364 and the lower surface 366. Theknobbed, rigid shaft 326 also has opposite sides 368,370, each side ofwhich includes a groove 372 that runs along the length of the knobbed,rigid shaft 326 between the ankle section 342 and the proximal end 338.The grooves 372 are preferably rectangular (or square) in cross sectionfor reasons that will become apparent below. As such each of the grooves372 have a front (or first) surface 374 and a rear (or second) surface376. It is noted that the front surface 374 faces the rear portion ofthe knobbed, rigid shaft 326, while the rear surface 376 faces the frontof the knobbed, rigid shaft 326. The grooves 372 cooperate with theother portions of the seal assembly 320 to ensure that the outerfloating element 328 and the second sealing element 330 are properlypositioned, as discussed in more detail below. Since the grooves 372 aresmaller than the sides 368,370, the sides 368,370 present a flat surfacefor the outer floating element 328, discussed below.

Illustrated in FIGS. 20 and 21 is a cross section of the knobbed, rigidshaft 326 at the weakened notch feature 336. The weakened notch feature336 has a smaller cross section than any other portion of the knobbedrigid shaft 326. This allows for the knobbed, rigid shaft 326 to bebroken at this point upon activation of the insertion device 300 byexerting a force in the direction of the length of the knobbed, rigidshaft 326, causing the knobbed, rigid shaft 326 to break at the weakenednotch feature 336. In order to prevent the weakened notch feature 336from breaking prematurely, a c-shaped ring may be clipped into theweakened notch feature 336 as noted above. The width of notch feature336 is sized to equal the space between knobs 362 so that second seal328 can easily transition over notch feature 336 upon automaticactivation of device 300. The c-shaped ring prevents the knobbed, rigidshaft 326 from being tilted off center and breaking prematurely.

In FIG. 21, the groove 372 in the knobbed, rigid distal shaft section334 preferably flares outward at 372 a at the weakened notch feature336, to ensure that the outer floating element 328 and its componentsfloat over the the weakened notch feature 336 during operation withoutskiving on a portion of the groove 372 at that location.

The flexible member 324, along with distal section 340, assists insealing the opening in the vessel wall. The flexible member 324 isillustrated as being a circular member having an opening 378 in a middleportion thereof. The flexible member 324 has a thickness t, which ispreferably around 0.2 millimeters. Since the flexible member 324 ispreferably made from 70% L-lactide 30% caprolactone copolymer, it isable to being deformed as described below. As illustrated in FIGS. 16Band 17, the flexible member 324 is disposed around the ankle portion 342and against the top surface 350 of the distal section 340. Preferably,the flexible member 324 is attached to the top surface 350 of the distalsection 340. It can be attached in any number of ways, includingheat-staking or welding the flexible member 324 to the top surface 350,using an approved adhesive between the flexible member 324 and the topsurface 350 flexible member 324. Alternatively, the opening 378 could beslightly smaller than the diameter of the ankle portion 342, preventingthe flexible member 324 from moving along the length of the knobbed,rigid shaft 326 at the ankle portion 342. As explained in more detailbelow, the flexible member 324 is disposed between the distal section340 and the inner wall of the vessel. See, e.g., FIG. 30.

While the opening 378 is a contained opening, it is also possible thatthere be a slit (or small path) from the outside of the flexible member324 allowing the flexible member to be disposed around the ankle portion342 without having to slide it the length of the knobbed, rigid shaft326.

Second sealing element 330 is shown in more detail in FIGS. 22A and 22B.The second sealing element 330 has a proximally facing surface 380 and asloped distally facing surface 382. An internal opening 384 defined bythe internal surface 386 extends between the proximally facing surface380 and the sloped distally facing surface 382. The internal surface 386has extending therefrom and into the internal opening 384 projections388 that interface with and engage the knobs 362 with an interferencefit such that second sealing element 330 and knobbed, rigid shaft 326function as a one way latch assuring an adequate compression forceregardless of the blood vessel wall thickness.

Referring to FIG. 22B, the internal opening 384 of second sealingelement 330 have two flat surfaces 390 on opposite sides of the internalopening 384 that interface with flat surfaces 368,370 of knobbed rigidshaft 326 to provide rotational stability of the seal assemblycomponents 328,330, thus assuring that the sloped distally facingsurface 382 and the fully deployed outer floating foot 328 remainparallel with the distal section 340 of the first sealing element 322and the proximal or top surface 350 in particular.

The outer floating element 328 is illustrated in detail in FIGS.23A-24B. The outer floating element 328 is generally rectangularlyshaped and has a rectangularly shaped central aperture 400 and twoprotrusions 402 that extend from the longest side walls 404 into theaperture 400. The outer floating element 328 has a top surface 406 and abottom surface 408, which are generally parallel to one another. Theprotrusions 402 are configured to engage and allow the outer floatingelement 328 to travel along the knobbed, rigid shaft 326 in the grooves372. The protrusions are somewhat tear drop shaped, but have two flatsurfaces, a first flat surface 410 and a second flat surface 412. Theouter floating element 328 also has two inclined surfaces 414 and 416,one at either end of the outer floating element 328 and defines the endsof the aperture 400. The first flat surface 410 is at an angle βrelative to the top and bottom surfaces 406,408 of outer floatingelement 328. See FIG. 23A. Preferably angle β is about a 45 degree anglebut could be anywhere between 35 and 55 degrees and still fall withinthe scope of the present invention. The second flat surface 412 makes anangle

relative to the top and bottom surfaces 406,408. See FIG. 23A.Preferably angle

is about a 19 degree angle but could be anywhere between 15 and 25degrees and still fall within the scope of the present invention. Aswould be obvious, the two inclined surfaces 414 and 416 are alsoparallel to the second flat surface 412 as will be explained below.

Turning to FIGS. 24A and 24B, the positioning of the outer floatingelement 328 will be explained. In both figures, the dotted linescorrespond to the surfaces of the knobbed, rigid shaft 326 presented tothe outer floating element 328. In particular, the two middle linescorrespond to the front (or first) surface 374 and the rear (or second)surface 376 of the groove 372. Thus, the two protrusions 402 will slidealong between those two middle lines. The two outside lines correspondto the upper 364 surface and the lower 366 surface of the outer floatingelement 328. In FIG. 24A, the outer floating element 328 is illustratedin its stored version—to be inserted into, or already in the inserter.Thus, in the position of FIG. 24A, the outer floating element 328 has,relative to the rest of the seal assembly 320, the smallest profile andwill allow it to pass through a smaller cannula.

FIG. 24B illustrates the outer floating element 328 relative to theknobbed, rigid shaft 326 after it exits the cannula. That is, the outerfloating element 328 has been engaged by the second sealing element 330(not shown in the figures) and because the size of the projections 402relative to the groove 372, the outer floating element 328 can rotate(clockwise in FIG. 24B) relative to the knobbed, rigid shaft 326 to bein a position to engage the outside of the vessel. See, e.g., FIGS. 30and 31.

An inserter 450 is illustrated in FIGS. 25-27. The embodiment of theinserter 450 illustrated has a first portion 452 and a second portion454, which are illustrated as a top half and a bottom half. Naturally,the portions 452,454 could have other names (e.g., side portions) andstill fall within the scope of the present invention. The inserter 450has a proximal end 456 and a distal end 458. When the portions 452,454are assembled, a longitudinal opening 460 is created that extendsthrough the inserter 450. The inserter 450 preferably has at theproximal end 456 a proximal section 462 that has a constant diameterouter surface and a constant diameter for the longitudinal opening 460at the proximal section 462. The proximal section 462 of each of theportions 452,454 has a a number of projections 464 and openings 466. Theprojections 464 of one portion 452,454 correspond to the openings 466 ofthe other portion 452,454, thereby allowing the two portions 452,454 tobe brought together and aligned for use. Forward of the proximal section462 is a reduced diameter area 468, which then increases in diameter at470 creating a shoulder 472 before tapering back down to a smaller outerdiameter at the distal end 458.

The longitudinal opening 460 in inserter 450 allows for the sealassembly 320 to be loaded therein, sterilized, stored, and then used bya doctor. Typically, if a seal assembly is contained within a confinedspace and then sterilized, the sterilization causes the seal assembly tomaintain the configuration in which it is sterilized. Even if thematerial normally was some shape memory (allowing the material to springback to its original shape or configuration), the sterilization has beenfound by the inventor to prevent the materials from returning to theiroriginal configuration. Thus, the current inserter 450 allows for theseal assembly 320 to be loaded without any real change in configuration.The longitudinal opening 460 has been designed to hold the first sealingelement 322, a flexible member 324, a knobbed rigid shaft 326, an outerfloating element 328, and a second sealing element 330 without thisissue. To do so, however, the portion 454 has an aperture 474 to allowfor the heel 356 of the distal section 340 to be disposed therein. Whilethe aperture 474 is illustrated as extending through the portion 454, itis possible that there only be a depression, groove, or dimple that doesnot penetrate all the way through the portion 454.

Turning to FIG. 26, a cross section of the inserter 450 with the sealassembly 320 disposed therein illustrates the position of the sealassembly 320 within the inserter 450. As should be clear, the crosssection is through the center of both portions 452,454. It should alsobe noted that the distance D1 of between the two portions 452,454 of thelongitudinal opening 460 is generally constant. The position of theouter floating element 328 relative to the knobbed, rigid shaft 326 andthe position of the flexible member 324 relative to the distal section340 allow the inserter to have a minimum size.

FIG. 27 illustrates the the seal assembly 320 within the inserter 450from above the inserter 450. In this view, it is clear that the diameterD2 of the longitudinal opening 460 is larger in the horizontal plane;allowing the flexible member 324 to hold its original configuration. Thelongitudinal opening 460 at the proximal section 462 is also sized toallow the outer floating element 328 and the second sealing element 330to pass therethrough. The longitudinal opening 460 at the distal end 458is smaller than the diameter D2, but the flexible member 324 and thedistal section 340 can be deformed and then return to their to originalshape for use in the patient.

A method of using the current invention in conjunction with FIGS. 28-31is as follows: The device 300, and in particular the seal assembly 320is inserted into inserter 450 that surrounds seal assembly 320 such thatseal assembly 320 can pass through sheath valve 132 and to the sheath120. This allows for the simultaneous removal of the device 300 and thesheath 120, if the sheath is not removed prior to the activation of theautomatic mechanism. Inserting pusher 316 through sheath 120, includingvalve 132 and cannula 122, causes at least a portion of seal assembly320 to exit the distal end of cannula 122 and into blood vessel 140. SeeFIG. 29. The sheath 120 may then be removed from the device 300. Pullingon the closure device 300, the flexible member 324 and the distalportion 340 of first sealing element 322 engages the interior bloodvessel wall 142. See FIG. 30. This would also remove the second sealingelement 330, the outer floating element 328, and the pusher 316 fromwithin the blood vessel 140. Continuing to pull on the sealing assembly320, and therefore flexible shaft 318, triggers the automatic mechanism150 in the closure device 300, which pushes pusher 316, and which inturn pushes second sealing element 330, and the outer floating element328 distally such that the outer floating element 328 is in contact withouter wall of blood vessel 140. This will sandwich the outer floatingelement 328, the blood vessel 140 and the flexible member 324 betweenthe first and second sealing elements 322, 330 such that the opening inblood vessel 140 is hemostatically sealed, as shown in FIG. 31.

It will be apparent to those skilled in the art that variousmodifications and variations can be made to the present inventionwithout departing from the spirit and scope of the invention. Thus, itis intended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

1. A seal assembly for sealing an opening in the wall of a blood vessel,the blood vessel having an interior wall surface, exterior wall surface,and a lumen, the seal assembly comprising: a first sealing element forplacing inside the lumen of the blood vessel; a shaft formed with thefirst sealing element and in a predetermined configuration relative tothe first sealing element, the shaft having a length sufficient toextend through the opening of the blood vessel and at least a portion ofany overlying tissue, and the shaft and the first sealing element are asingle one-piece component; an outer floating element slidingly movablealong the shaft, the outer floating element having a proximal surfaceand a distal surface; and a second sealing element, the second sealingelement slidingly movable relative to the first sealing element alongthe shaft to engage the outer floating element and configured toposition the distal surface of the outer floating element against theexterior wall surface of the blood vessel to seal the opening in theblood vessel. 2-6. (canceled)
 7. The seal assembly for sealing anopening in the wall of a blood vessel according to claim 1, wherein theshaft has at least two sides, the at least two sides each having agroove along a portion thereof and the outer floating element has anaperture to receive the shaft therethrough, the aperture generally beingrectangular and having two protrusions extending into the aperture andconfigured to the groove on a respective side of the shaft.
 8. The sealassembly for sealing an opening in the wall of a blood vessel accordingto claim 1, wherein the shaft has four sides, two of the four sideshaving a plurality of equally spaced projections along a length thereof.9. The seal assembly for sealing an opening in the wall of a bloodvessel according to claim 7, wherein each of the protrusions has a firstsurface capable of engaging a first wall of the groove and a secondsurface capable of engaging a second wall of the groove.
 10. The sealassembly for sealing an opening in the wall of a blood vessel accordingto claim 9, wherein when the first surface engages the first wall of thegroove, the distal surface of the outer floating element is disposedrelative to the first wall at an angle of between 35 and 55 degrees. 11.The seal assembly for sealing an opening in the wall of a blood vesselaccording to claim 10, wherein the angle is 45 degrees
 12. The sealassembly for sealing an opening in the wall of a blood vessel accordingto claim 9, wherein when the second surface engages the second wall ofthe groove, the second wall facing the first wall across the groove, andthe distal surface of the outer floating element is disposed relative tothe second wall at an angle of between 15 and 25 degrees.
 13. The sealassembly for sealing an opening in the wall of a blood vessel accordingto claim 12, wherein the angle is 19 degrees.
 14. The seal assembly forsealing an opening in the wall of a blood vessel according to claim 1,wherein the shaft has a reduced portion, the reduced portion having across section being smaller than a cross section of any other portion ofthe shaft.
 15. The seal assembly for sealing an opening in the wall of ablood vessel according to claim 1, further comprising an inserter, theinserter comprising a housing have a first portion and a second portion,the first portion and second portion having a proximal end and a distalend; a longitudinal opening extending through the housing when the firstand second portion are connected to one another and opening at theproximal and distal ends; an aperture in one of the first and secondportions, the aperture configured to receive a portion of the firstsealing element when the first and second portion are connected to oneanother and the seal assembly is inserted therein.
 16. The seal assemblyfor sealing an opening in the wall of a blood vessel according to claim1, wherein the longitudinal opening has a first opening portion and asecond opening portion, the first opening portion having a constantdiameter and the second opening portion has a variable diameter.
 17. Theseal assembly for sealing an opening in the wall of a blood vesselaccording to claim 16, wherein the aperture is disposed in the inserterat the second opening portion.
 18. The seal assembly for sealing anopening in the wall of a blood vessel according to claim 15, where inthe distal surface of the outer floating member is disposed relative tothe shaft at an angle of between 15 and 25 degrees.
 19. (canceled) 20.The seal assembly for sealing an opening in the wall of a blood vesselaccording to claim 15, the inserter has an outer surface, the outersurface having a first outer diameter at the distal end thereof and asecond diameter between the distal and proximal ends, the seconddiameter being larger than the first diameter.
 21. (canceled)
 22. A sealassembly for sealing an opening in the wall of a blood vessel, the bloodvessel having an interior wall surface, exterior wall surface, and alumen, the seal assembly comprising: a first sealing element for placinginside the lumen of the blood vessel; a shaft formed with the firstsealing element and in a predetermined configuration relative to thefirst sealing element, the shaft having a length sufficient to extendthrough the opening of the blood vessel and at least a portion of anyoverlying tissue, and the shaft and the first sealing element are asingle one-piece component; a flexible member surrounding at least aportion of the shaft adjacent the first sealing element; and a secondsealing element, the second sealing element slidingly movable relativeto the first sealing element along the shaft and configured to seal theopening in the blood vessel.